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510(k) K850403

MEC DISTAL FEMORAL BOLT by Pfizer, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
February 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K892360 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (June 5, 1989)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K854726 — MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (February 24, 1986)
  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)
  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K850413 — MEC HIP BOLT (July 15, 1985)
  • K851971 — SERIES 7000/HOLTER RECORDER (June 20, 1985)

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